Financial Toxicity and Quality of Life in Patients With TGCT

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT04531709
Collaborator
(none)
60
1
57.5
1

Study Details

Study Description

Brief Summary

This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors.

Condition or Disease Intervention/Treatment Phase
  • Other: Comprehensive Score for financial toxicity (COST)
  • Other: Functional Assessment of Cancer Therapy: General (FACT-G)
  • Other: EORTC QLQ C-30
  • Other: EORTC QLQ-TC26.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Financial Toxicity and Quality of Life in Patients With Testicular Germ Cell Tumors
Actual Study Start Date :
Feb 15, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Recently diagnosed TGCT

Other: Comprehensive Score for financial toxicity (COST)
Measure indirect and direct health care cost that burden patients and their loved ones.

Other: Functional Assessment of Cancer Therapy: General (FACT-G)
General quality of life instrument

Other: EORTC QLQ C-30
Assess quality of life in cancer patients

Other: EORTC QLQ-TC26.
To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire.

Long-term survivors of TGCT

Other: Comprehensive Score for financial toxicity (COST)
Measure indirect and direct health care cost that burden patients and their loved ones.

Other: Functional Assessment of Cancer Therapy: General (FACT-G)
General quality of life instrument

Other: EORTC QLQ C-30
Assess quality of life in cancer patients

Other: EORTC QLQ-TC26.
To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire.

Outcome Measures

Primary Outcome Measures

  1. Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high. [5 years]

Secondary Outcome Measures

  1. Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Recently diagnosed TGCT

  • Patients with histologically or clinically confirmed germ cell tumor.

  • Age > 18 years of age.

  • Anticipated treatment with multicycle (> 2 cycles) / multiagent chemotherapy

  • Within 4 weeks of starting C1D1 chemotherapy

  • Signed informed consent

  • Long-term survivors

  • Age > 18 years of age

  • Patients with histologically or clinically confirmed germ cell tumor.

  • Completed treatment for germ cell tumor with multicycle (> 2 cycles) / multiagent chemotherapy.

  • Within years 1-5 of surveillance since Day 1 of last cycle of chemotherapy

  • Signed informed consent

Exclusion Criteria:
  • Recently diagnosed TGCT

  • Patients planned to receive <2 cycles of chemotherapy

  • Starting chemotherapy greater than 4 weeks after signing consent and completing initial survey.

  • Starting chemotherapy prior to consenting and completing initial survey.

  • Long-term survivors

  • Patients undergoing active chemotherapy

  • Patients who did not complete 1st line chemotherapy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mays Cancer Center San Antonio Texas United States 78229

Sponsors and Collaborators

  • The University of Texas Health Science Center at San Antonio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT04531709
Other Study ID Numbers:
  • CTMS 20-0061
  • HSC20200462E
First Posted:
Aug 28, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022